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Principal Safety Scientist

External
ICON plc logoIcon · Sofia, Bulgaria
Full-timeOn-site3w ago
AccessibilityComplianceDocumentationMentoringRisk Management
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Responsibilities

  • Lead signal detection and safety surveillance activities , ensuring timely identification, evaluation, and documentation of safety signals
  • Manage and coordinate aggregate safety reports (e.g. PSUR, DSUR), including planning, data review, and authoring/review
  • Author and oversee Risk Management Plans (RMPs) and support implementation of risk minimisation strategies
  • Design and conduct literature searches and reviews to support safety monitoring and regulatory requirements
  • Act as a pharmacovigilance lead on projects, partnering with cross-functional teams and clients
  • Provide scientific input and review of key safety documents (e.g. IB, CCDS/CCSI, protocols, ICSRs)
  • Contribute to process improvements, compliance activities, and mentoring of junior team members
  • Your Profile:
  • 5+ years of experience in Pharmacovigilance / Drug Safety
  • Advanced degree in life sciences, pharmacology, or a related field; relevant certifications preferred.
  • Strong expertise in signal detection, safety surveillance, and aggregate reporting
  • Proven experience in authoring Risk Management Plans (RMPs)
  • Proven ability to analyze complex safety data and make informed decisions based on scientific evidence.
  • Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and external stakeholders.
  • A commitment to maintaining high standards of quality and compliance in all safety-related activities.
  • #LI-MK1
  • Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
  • Rewards & Benefits
  • ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
  • Benefits may include:
  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways
  • Benefits may vary depending on role and location.
  • Visit our careers site to read more about the benefits ICON offers.
  • Inclusion and Accessibility
  • ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
  • If you require reasonable accommodations during the recruitment process, please let us know or submit a request here .
  • Are you a current ICON Employee? Please

Benefits

Health insuranceDental insuranceVision insurance

Additional Information

Principal Safety Scientist - Poland or Bulgaria - homebased ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. We are currently seeking a Principal Safety Scientist to join our diverse and dynamic team. As a Principal Safety Scientist at ICON, you will be responsible for leading safety assessments and pharmacovigilance activities to ensure the safety and efficacy of pharmaceutical products. Your expertise will be essential in driving the development of risk management strategies and ensuring compliance with regulatory requirements.


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